Note: Although this FDA-483 is an accurate representation of the original FDA-483 issued to the firm, it is not an exact copy. Slight modifications to the original FDA-483 have been made to accommodate its conversion to the HTML format. A scanned copy of the original letter is available in PDF at the bottom of this page.
60 Eighth Street
Atlanta, GA 30309
12/21/2005 - 01/19/2006
TO: Robert R. Petruzzi Plant Manager
Diamond Pet Food Processors of South Carolina, LLC
100 WoodTrail Drive
Gaston, SC 29053
Pet Food Manufacturer
Item #1: Aflatoxin testing of finished pet food product retention samples of pet food manufactured between Sept 1, 2005 and Nov. 30, 2005 showed 16 batches of various pet food products with an Aflatoxin level 20 ppb or greater. Examples of aflatoxin test results in some of the product batches:
|Batch Code||Manufacturing Date||Highest Aflatoxin Level in Retention Sample|
|Oct 11, 2005||376 ppb|
|Oct 11, 2005||280 ppb|
|Oct 12, 2005||96 ppb|
|Oct 4, 2005||75 ppb|
|Oct 3, 2005||61 ppb|
Item #2: Outside laboratory aflatoxin testing of four accepted incoming shipments of whole corn showed high levels of aflatoxin.
|Weight Ticket||Date Received||Aflatoxin Level|
|G19519||Sept. 16, 2005||90 ppb|
|G20213||Oct. 11, 2005||1851 ppb|
|G20828||Oct 31, 2005||111 ppb|
|G21488||Nov. 21, 2005||123 ppb|
These whole corn shipments were used in the manufacturing of various pet food products.
#3: Firm’s written procedures require each shipment of incoming corn shipment be checked for aflatoxin. Records for the Aflatoxin testing of incoming whole corn did not always document that the tests were done or that the [ REDACTION ] test was performing properly.
Confirmatory aflatoxin testing on whole corn retention samples have found four incidences of false negative [ REDACTION ] tests and two false positive [ REDACTION ] tests. For example:
|Weight Ticket||Date||[ REDACTION ] Result||2nd Test Result|
B.The Incoming Ingredient Inspection form did not list the results of the
[ REDACTION ] test for approximately 12 of the [ REDACTION ] incoming whole shipments during September and October 2005.
C. On Dec. 7, 2005 only nine of [ REDACTION ] shipments of whole corn were tested for Aflatoxin.
D. There was no documentation of running a positive or negative control to ensure that the reagents of the [ REDACTION ] test were functioning properly.
#4: As per the firm’s written procedures, retention samples of all bulk materials (including whole corn) are to be collected. Over 50% of the retention samples of incoming whole corn shipments from Sept. 1, 2005 to Nov. 30, 2005 are missing. Quality Control personnel who are responsible to ensure the collection and storage of retention samples failed to notice the retention samples were not being collected or were missing. Without the retention samples there can be no secondary check for Aflatoxin in those incoming corn shipments.
#5: Accepted incoming bulk feed ingredients do not always meet the firm’s ingredient specifications. Some of these ingredient specifications include ranges for protein, moisture, fat, ash, and fiber. The five listed specifications are checked by Near InfraRed Spectroscopy (NIR). Handwritten written results on the Receiving NIR Test Results Report for the time period 1/3/06 to 1/17/06 indicated that:
A. 17 of 21 accepted shipments of wheat flour failed three or more of the five specifications tested by NIR.
B. All five accepted shipments of rice bran failed four out of five specifications tested by NIR.
C. Six of seven accepted shipments of Chicken By-Product Meal (Low Ash) failed all four specifications tested by NIR.
D. There was no documentation of NIR test results for whole corn for 2005
#6: Written procedures for receiving bulk materials do not reflect current practices. For example, verbal directions were made to disregard the black light testing of incoming corn shipments and test all corn shipments for aflatoxin. The form, Incoming Ingredient Inspection, for recording the inspection results of bulk material was changed at the first part of 2005.
#7: No acceptance criteria or testing conducted on fines stored outside in trailers.
#8: No BSE warning statement on invoice of pet food scrapes sold to local hog farmer.
FDA EMPLOYEE'S NAME, TITLE, AND SIGNATURE:
E. Harold Blackwood Investigator
The observations of objectional conditions and practices listed on the front of this form are reported:
Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or
To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration.